Luma Vision Limited
FDA 510(k) & PMA Approved Devices — 3 products
Total Devices3
Categories1
Latest FDA decision2026-07-24
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | OBJ | 2026-07-24 | View |
| 510(k) | K260885 | VERAFEYE Imaging and Guidance System (VF-VIS-002) | 2026-06-15 | View | |
| 510(k) | K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | OBJ | 2025-03-24 | View |
No matching devices.
Related Clinical Trials
NCT06293430Registry on Luma Vision's VERAFEYE System (ENLIgHT)NOT_YET_RECRUITINGNCT06895187Catheter Ablation Using a Novel Navigation and Imaging SystemNOT_YET_RECRUITINGNCT07210151Anatomical Navigation for Guided Electrophysiology in AFL and AFibRECRUITINGNCT07271238Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation ProceduresRECRUITINGNCT07686328A Multicenter Feasibility Study With the VERAFEYE Imaging and Guidance System as Anatomical Navigation SystemNOT_YET_RECRUITING